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RINIWEL 120 mg FILM-COATED TABLETS

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About the medicine

How to use RINIWEL 120 mg FILM-COATED TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the Patient

Riniwel 120 mg Film-Coated Tablets EFG

fexofenadine hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for this medication exactly as stated in this package leaflet or as directed by your doctor or pharmacist.

  • Keep this package leaflet, as you may need to read it again.
  • If you need advice or more information, consult your pharmacist.
  • If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
  • You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet

  1. What is Riniwel and what is it used for
  2. What you need to know before taking Riniwel
  3. How to take Riniwel
  4. Possible side effects
  5. Storage of Riniwel
  6. Package Contents and Additional Information

1. What is Riniwel and what is it used for

Riniwel contains fexofenadine hydrochloride, which is a non-drowsy antihistamine.

Fexofenadine is used in adults and adolescents 12 years of age and older to relieve symptoms associated with allergic rhinitis (such as hay fever), such as sneezing, itching, runny or stuffy nose, and itchy, red, or watery eyes.

You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before taking Riniwel

Do not take Riniwel:

  • If you are allergic to fexofenadine or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before taking Riniwel if:

  • You have liver or kidney problems.
  • You have or have had a heart condition, as this type of medication may cause an irregular or faster heartbeat.
  • You are an elderly patient.

If you are in any of these situations or are unsure, consult your doctor before taking Riniwel.

Children and Adolescents

Fexofenadine is not recommended for children under 12 years of age.

In children 6 to 11 years old: the appropriate formulation for administration and dosing in this population is fexofenadine hydrochloride 30 mg.

Other Medications and Riniwel

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

If you are taking apalutamide (a medication for prostate cancer), as the effect of fexofenadine may be reduced.

It is especially important to talk to your doctor before taking fexofenadine if you are also taking any of the following medications:

  • An antibiotic used to treat certain bacterial infections (erythromycin)
  • An antifungal used to treat fungal infections (ketoconazole).

These medications increase the amount of fexofenadine absorbed.

Indigestion products containing aluminum and magnesium may alter the action of fexofenadine by reducing the amount of medication absorbed.

A gap of about 2 hours is recommended between taking fexofenadine and the indigestion product.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take fexofenadine if you are pregnant unless advised by your doctor.

Fexofenadine is not recommended during breastfeeding.

Driving and Using Machines

Fexofenadine is unlikely to affect your ability to drive or use machines. However, make sure these tablets do not make you feel drowsy or dizzy before driving or operating machinery.

Riniwel contains Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Riniwel contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Riniwel

Follow the administration instructions for this medication exactly as stated in this package leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults and Children 12 years and older

The recommended dose is one tablet (120 mg) per day.

Take the tablet with water before a meal.

This medication starts to relieve your symptoms in 1 hour and lasts 24 hours.

If you take more Riniwel than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of an overdose in adults are dizziness, drowsiness, fatigue, and dry mouth.

If you forget to take Riniwel

Do not take a double dose to make up for forgotten doses.

Take the next dose at the scheduled time.

If you stop taking Riniwel

If you stop taking fexofenadine, your symptoms may return.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Consult your doctor immediately and stop taking Riniwel if you experience:

  • Facial swelling, lips, tongue, or throat, and difficulty breathing, as these may be signs of a severe allergic reaction.

The following unwanted effects have been reported in clinical trials with an incidence similar to that observed in patients who did not receive the medication (placebo).

Common Side Effects(may affect up to 1 in 10 people):

  • Headache
  • Drowsiness
  • Feeling of discomfort (Nausea)
  • Dizziness

Uncommon Side Effects(may affect up to 1 in 100 people):

  • Fatigue
  • Numbness

Additional Side Effects(Frequency not known: cannot be estimated from available data) that may occur are:

  • Difficulty sleeping (insomnia)
  • Sleep disorders
  • Nightmares
  • Nervousness
  • Blurred vision
  • Fast or irregular heartbeat
  • Diarrhea
  • Hives and itching
  • Rash
  • Severe allergic reactions that can cause swelling of the face, lips, tongue, or throat, flushing, chest tightness, and difficulty breathing.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Riniwel

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE Point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Riniwel

  • The active ingredient is fexofenadine hydrochloride. Each film-coated tablet contains 120 mg of fexofenadine hydrochloride, equivalent to 112 mg of fexofenadine.
  • The other ingredients are:

Core of the tablet: croscarmellose sodium, lactose, lactose monohydrate, corn starch, colloidal anhydrous silica, pregelatinized starch, stearic acid.

Coating film: red iron oxide (E172), yellow iron oxide (E172), hypromellose 2910 6 mPas (E464), macrogol 400 (E1521), titanium dioxide (E171).

Appearance of the Product and Package Contents

Film-coated tablet.

Riniwel 120 mg are film-coated tablets, biconvex, capsule-shaped, peach-colored, with a beveled edge, engraved with "FE" on one side and "120" on the other side.

Riniwel 120 mg film-coated tablets EFG are available in blisters containing 7, 10, 15, 20, 30, 50, 60, and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19

2700-487 Amadora

Portugal

or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medication is authorized in the Member States of the European Economic Area under the following names:

France:

Fexofenadine Arrow 120 mg film-coated tablet

Germany:

Fexofenadin PUREN 120 mg film-coated tablets

Netherlands:

Fexofenadine HCl Aurobindo 120 mg, film-coated tablets

Poland:

Fexofenadine Aurovitas

Portugal:

Fexofenadina Nazonite

Spain:

Riniwel 120 mg film-coated tablets EFG

Date of the last revision of this package leaflet: April 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).

Online doctors for RINIWEL 120 mg FILM-COATED TABLETS

Discuss questions about RINIWEL 120 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Dr. Shalko works specifically with urgent and short-term problems, providing practical recommendations and helping patients determine the safest next step. She explains symptoms clearly, guides patients through decision-making and offers straightforward medical advice for everyday acute issues.She does not provide long-term management of chronic conditions, ongoing follow-up or comprehensive care plans for complex long-term illnesses. Her consultations are designed for acute symptoms, sudden concerns and situations where timely medical input is important.With clinical experience in both paediatrics and general medicine, Dr. Shalko confidently supports adults and children. Her communication style is clear, simple and reassuring, helping patients feel informed and supported throughout the consultation.

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Dr Okeke focuses on general internal medicine and adult primary care, combining clinical accuracy with careful attention to lifestyle, personal context, and everyday health concerns. His consultations are particularly well suited for people who seek medical advice online, live abroad, or need clear guidance without unnecessary complexity.

He provides online consultations covering symptom assessment, prevention, and long-term management of chronic conditions, helping patients understand what is happening and decide on appropriate next steps.

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Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Daniel Cichi

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Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

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Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

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Yevgen Yakovenko

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Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

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Experience and qualifications:

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Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

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Frequently Asked Questions

Is a prescription required for RINIWEL 120 mg FILM-COATED TABLETS?
RINIWEL 120 mg FILM-COATED TABLETS does not require a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in RINIWEL 120 mg FILM-COATED TABLETS?
The active ingredient in RINIWEL 120 mg FILM-COATED TABLETS is fexofenadine. This information helps identify medicines with the same composition but different brand names.
Who manufactures RINIWEL 120 mg FILM-COATED TABLETS?
RINIWEL 120 mg FILM-COATED TABLETS is manufactured by Aurovitas Spain, S.A.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of RINIWEL 120 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether RINIWEL 120 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to RINIWEL 120 mg FILM-COATED TABLETS?
Other medicines with the same active substance (fexofenadine) include FEXOFENADINE CIPLA 120 mg FILM-COATED TABLETS, FEXOFENADINE CIPLA 180 mg FILM-COATED TABLETS, FEXOFENADINE OPELLA 180 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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